Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 45

Results For "filing"

512 News Found

Solara Active Pharma Sciences PAT slides to Rs 29.71 cr in Q2FY22
News | November 12, 2021

Solara Active Pharma Sciences PAT slides to Rs 29.71 cr in Q2FY22

Solara Active Pharma Sciences has reported consolidated financial results for the period ended September 30, 2021.


Zydus Cadila receives approval for glycopyrrolate injection
Drug Approval | November 10, 2021

Zydus Cadila receives approval for glycopyrrolate injection

Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated


Novavax files emergency use listing with WHO for Covid-19 vaccine
Biotech | November 05, 2021

Novavax files emergency use listing with WHO for Covid-19 vaccine

All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO


Novavax files for approval of its Covid-19 vaccine in the UK
Biotech | October 27, 2021

Novavax files for approval of its Covid-19 vaccine in the UK

Filing marks first protein-based vaccine submitted to MHRA for authorization


4baseCare partners with U.S. based Cellworks for personalised cancer care
Digitisation | October 27, 2021

4baseCare partners with U.S. based Cellworks for personalised cancer care

The collaboration aims to deliver greater insights to the oncology fraternity, predict patient therapy responses and enable therapy selection resulting in optimal treatment outcomes.


Gland Pharma PAT declines to Rs 302 crore QoQ in Q2FY22
News | October 22, 2021

Gland Pharma PAT declines to Rs 302 crore QoQ in Q2FY22

The company’s wide therapeutic portfolio helped to sustain growth despite changing market demand


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Metropolis Healthcare board approves acquisition of Hitech for Rs 636 crore
Clinical Trials | October 16, 2021

Metropolis Healthcare board approves acquisition of Hitech for Rs 636 crore

The revised deal involves a cash consideration only as against the earlier proposal of cash and equity


Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D
News | October 06, 2021

Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D

The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)